Agency
The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.
The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.
FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.
Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.
Pharmacy Innovations is recalling Hydroxocobalamin 25MG/ML injectable vials nationwide due to insanitary facility conditions identified during FDA inspection that compromise sterility assurance.
Accord Healthcare is recalling Allopurinol 100 mg tablets due to the presence of a small piece of green plastic embedded in some tablets. The plastic poses a potential choking and ingestion hazard.
Nephron Pharmaceuticals is recalling 378 bags of 0.9% Sodium Chloride Injection nationwide due to manufacturing deviations that could create product carryover.
Wegmans Food Markets is recalling Organic Farm & Orchard Microgreens (1.75 oz) due to possible Salmonella contamination. The affected products with use-by dates December 17 and 24, 2022, were distributed across the Northeast and Mid-Atlantic.
Pharmacy Innovations is recalling magnesium chloride hexahydrate injectable (5 mL vials) distributed nationwide due to insanitary facility conditions that compromise product sterility assurance.
Pharmacy Innovations is recalling Lidocaine-PF 5% injectable solution nationwide due to insanitary facility conditions that compromised sterility assurance, discovered during FDA inspection.
Pharmacy Innovations is recalling Gentamicin bladder irrigation solutions due to FDA findings of insanitary facility conditions that compromised sterility assurance during manufacturing.
Meridian Bioscience is recalling 92 Revogene SARS-CoV-2 test kits due to potential specimen leakage from the cartridge, which could expose laboratory personnel to aerosolized COVID-19 virus.
Ascend Laboratories recalls 49,632 bottles of Metoprolol Succinate extended-release tablets (25 mg) nationwide and in Puerto Rico due to failure to meet dissolution specifications that could reduce drug effectiveness.
Pharmacy Innovations is recalling Tobramycin Fortified 15mg/mL Ophthalmic Solution nationwide due to insanitary facility conditions that compromised sterility assurance. Consumers should discontinue use and contact their healthcare provider.
Pharmacy Innovations recalls Phenol 10% injectable vials distributed nationwide due to insanitary conditions at the manufacturing facility that compromised sterility assurance.
Pharmacy Innovations is recalling Semaglutide injectable vials in multiple strengths distributed nationwide due to insanitary facility conditions compromising sterility. No illnesses have been reported.
Johnson & Johnson Surgical Vision is recalling Veritas Advanced Infusion Packs for a weld defect that may impair vacuum delivery during ophthalmic surgery. This could result in surgical delays and transient corneal swelling.
Lidl US TRADING is recalling Chef Select 2 Herb Baguettes due to undeclared wheat and milk allergens. Products were distributed to retail stores across the Mid-Atlantic and Southeast.
FALCON IMPORT & EXPORT LLC is recalling Alsultan Sweets Betefour because the product contains undeclared cashews, almonds, and pistachios not listed on the label. Consumers with tree nut allergies face allergic reaction risk.
FDA is recalling BSS Plus/Lidocaine Opth 1% injectable syringes manufactured by Pharmacy Innovations due to lack of sterility assurance found during a facility inspection.
Bakery on Main is recalling Full Circle Market Organic Oat & Honey Granola due to possible undeclared almonds. Consumers with almond allergies should not consume the product.
Pharmacy Innovations is recalling Flurbiprofen 0.04% ophthalmic solution nationwide due to insanitary conditions at the manufacturing facility that compromise product sterility.
Pharmacy Innovations is recalling Edetate Calcium Disodium 400MG/ML injectable vials nationwide due to insanitary manufacturing conditions that compromise sterility assurance.
Pharmacy Innovations is recalling Minoxidil 0.75% injectable due to insanitary facility conditions identified during FDA inspection that could compromise product sterility.
Pharmacy Innovations is recalling Ketamine 50mg/ml injectable vials nationwide due to insanitary facility conditions that compromised sterility assurance.
Align Technology is recalling Invisalign Express 10, Comprehensive, and Moderate systems due to a software defect that may produce incorrect numbers of aligners and incorrect packaging.
Pharmacy Innovations is recalling injectable PE1/PAPAV/ATROP/CHLORPROM drugs due to insanitary facility conditions that compromise product sterility. FDA inspection found conditions that do not ensure the safety of these injectable medications.
Pharmacy Innovations is recalling Voriconazole 10mg/ml ophthalmic solution nationwide because FDA inspection found insanitary facility conditions that compromised product sterility assurance.
Pharmacy Innovations is recalling injectable Vitamin D3 products nationwide due to insanitary facility conditions that compromised sterility assurance. No illnesses have been reported.